Industry Landscape

Vaccines are one of the most powerful and cost effective health interventions available. Yet preventable diseases still cost millions of lives each year. Vaccine companies are a key link in the chain to each successful vaccination.

For the first time, the Access to Vaccines Index has mapped how vaccine companies are responding to global calls to increase immunisation coverage. It finds that the eight companies measured approach access to vaccines in differing ways, generally linked to whether their businesses are focused more on developing new vaccines or on marketing existing ones, or on both.

Some companies have portfolios of highly profitable vaccines and small vaccine pipelines: here, companies’ access considerations mainly relate to pricing, registration and supply. Other companies have small portfolios but larger pipelines supported by proportionally high investments in vaccine R&D. For these companies, the access-to-vaccines focus is on ensuring vaccines in development will meet global health needs and on putting measures in place to ensure that successful vaccines will be accessible. Of the six companies evaluated across all areas of assessment, GSK performs the best, with Sanofi also performing well across the board. Of the eight companies evaluated in Research & Development, GSK also leads, followed closely by Johnson & Johnson. The other companies demonstrate mixed performances across the different areas evaluated.

In Research & Development, GSK and Johnson & Johnson lead, with strong yet differing approaches. GSK has the largest pipeline, while Johnson & Johnson makes the largest R&D investments as a proportion of vaccine revenue. Both companies aim to address high-need vaccine gaps, and both have access plans in place for over half their late-stage vaccine candidates.

In total, the eight companies evaluated have 89 projects in the pipeline for 35 of the 69 diseases in scope. Many of the 34 unaddressed diseases currently have no vaccines. Six dis- eases/pathogens receive the most attention: pneumococcal disease (9 projects), HPV and seasonal influenza (6 each), meningococcal disease and RSV (5 each), and dengue (4). Almost one-third of projects target diseases highly prioritised by WHO for vaccine R&D. The 89 projects in the pipeline are relatively evenly split between developing new vaccines on the one hand and adapting existing ones on the other (52% and 48% respectively). Both types of vaccine R&D are critical for facilitating widespread immunisation. Over half of late- stage projects have one or more measures in place to ensure the vaccine’s future accessibility. Company investment in vac- cine R&D varies, with investments ranging from less than 10% to 253% of a company’s global vaccine revenue.

Looking ahead in R&D

To ensure the long-term relevance and sustainability of their vaccine businesses, companies must invest sufficient vaccine profits into vaccine R&D. This also entails responding to R&D gaps prioritised by global health stakeholders, designing vaccine characteristics to address specific access barriers, and making clear plans to ensure rapid uptake where needed. While commercial market incentives drive vaccine R&D for some diseases, for others – in particular those that predominantly affect populations in low- and middle-income countries – potential profitability is low: alternative external incentives may be necessary to support this work where traditional incentives are lacking.

In Pricing & Registration, GSK leads, followed by Merck & Co., Inc. and Sanofi with equal total scores. GSK’s pricing strategy for vaccines is the most sensitive to each country’s ability to pay, relative to peers’ strategies. GSK and Merck & Co., Inc. lead in transparency, publishing their complete pricing strategies and reporting that they do not prohibit governments from publishing manufacturer prices. Sanofi is the leader in registration, filing to register most of its relevant vaccines in 30-50% of both low- and lower-middle-income countries in scope.

The six companies evaluated each consider multiple factors when setting vaccine prices, the combination of which is unique to each company and dependent on their portfolio. Across all companies, the most frequently considered factor is whether a country is eligible for Gavi support. This is followed by Gross National Income per capita, which is considered by four companies for at least some low- and middle-in- come countries. Some companies publish their complete pricing strategies online for all vaccines, yet in general, the transparency of pricing strategies varies. Most companies state that they do not include clauses in government contracts that pre- vent manufacturer prices being published. Vaccines are not being led for registration widely: for the 91 vaccines that qualify for analysis, the registration process has begun in less than a quarter of low-income countries and lower-middle income countries within the scope of the Index.

Looking ahead in Pricing & Registration

When pricing vaccines, companies need to address affordability systematically – especially for countries that receive no support from Gavi and do not participate in pooled procurement via PAHO or UNICEF. Companies can form and share clear pricing strategies for all low- and middle-income countries. Companies should also enable global information sharing about vaccine prices to promote a more competitive environment, facilitate negotiations and help ensure that prices are fair. There is also a gap in certain countries regarding vaccine registration: companies need to file to register vaccines according to public health need. In turn, governments and procurers must invest sufficiently in national regulatory systems and immunisation programmes in low- and middle-in- come countries.

In Manufacturing & Supply, GSK and Sanofi score highest. Both demonstrate strong processes and commitments to help ensure vaccine production meets demand. They further support global vaccine supply through capacity building in manufacturing. The two companies have also implemented vaccine presentations and packaging that help to overcome local access barriers (e.g., vaccines that are easier for health workers to administer).

The six companies evaluated are taking steps to align supply and demand at a global level, increasing the likelihood that some potential vaccine shortages are being detected, mitigated or prevented. Companies generally implement multiple internal processes to improve alignment between supply and demand; many also make commitments around continuing supply of needed vaccines. Companies are building vac- cine manufacturing capacity in some countries in scope: a relatively small number of middle-income countries with established vaccine production capacities. All companies take steps to ensure certain vaccines have packaging, presentations or features intended to help overcome barriers to access on the ground.

Looking ahead in Manufacturing & Distribution

The existence of ongoing vaccine shortages shows that communication and coordination between the industry, procurers and other stakeholders can be further improved. The industry must continue to monitor demand and improve approaches for preventing shortages. This is especially important – nationally and on a global level – where demand suddenly spikes, such as with disease outbreaks. To support access on the ground, companies can also ensure that vaccine presentations pose minimal challenges to local supply chains and health systems. There is further progress to be made in this area: partnerships with stakeholders who understand local needs and can put incentives in place for private-sector involvement may be useful here.

What does the industry look like?

The Index has compared key characteristics of each company included in the Index scope (see figure 2). The companies evaluated in the Access to Vaccines Index have diverse business models, which are reflected in their vaccine pipelines, portfolios, revenues and number of doses sold globally.

The industry is highly consolidated: the “big four” – GSK, Merck & Co., Inc., Pfizer and Sanofi – represent a large proportion (around 80%) of global vaccine revenues. While all companies within this group have very high vaccine revenues, there are also important differences between them: GSK and Sanofi have a large number of vaccines in their diverse portfolios, a relatively wide geographic spread and larger-than-average pipelines. Merck and Co., Inc. and Pfizer have smaller pipelines and portfolios, and sell fewer doses globally.

The area of each circle represents each company’s number of vaccine R&D projects (left) or vaccines on the market (right). Investment represents vaccine R&D investment in USD for diseases in scope over the 2014 and 2015 fiscal years. No. of doses sold represents the number of vaccine doses sold globally in 2015. Revenue represents global vaccine revenue in USD over the 2014 and 2015 fiscal years. Serum Institute of India’s pipeline is based on publicly available sources. It has additional projects for which the data are confidential. Daiichi Sankyo did not provide data on number of doses sold globally.

Serum Institute of India is also a major player of global public health importance, especially in terms of the number of vaccine doses produced and its wide geographic reach: its lower revenue reflects its high-volume, low-cost model. For Johnson & Johnson, vaccines currently represent a smaller part of the business – its revenue is low compared with other companies evaluated – but a promising vaccine pipe-line supported by a very high proportion of R&D investments (compared to revenue) indicates an increasing focus on vaccines in the future. Daiichi Sankyo and Takeda are smaller players that are important to the domestic Japanese vaccine market, with growing vaccines businesses. Neither currently markets vaccines in other countries, but the pipelines and R&D investments of both companies show potential and interest in contributing to the global vaccines market.

Four companies account for 80% of global vaccine revenues: GSK, Merck & Co., Inc., Pfizer and Sanofi. Often collectively referred to as the “big four”, they vary significantly by portfolio and pipeline size. All four have vaccines on the market that are of significant public health value.

Three of the other four companies in scope have larger pipelines than Merck & Co., Inc. or Pfizer. When their vaccine candidates leave the pipeline, there is potential for significant changes in the vaccine landscape – including increasing competition in key vaccine markets.

Serum Institute of India’s pipeline is based on publicly available sources. It has additional projects for which the data are con dential. Vaccines that were approved during the period of analysis are counted twice: in both the number of projects in the pipeline and in the number of vaccines on the market.

Pipeline and portfolio analysis: where is the industry focusing?

When it comes to vaccines, companies clearly concentrate on diseases with larger global markets: for example, the diseases with the most vaccines on the market are meningococcal disease, polio, seasonal influenza and viral hepatitis; the largest pipelines are for pneumococcal disease, seasonal influenza, HPV, meningococcal disease and RSV.

For the full portfolio and pipeline analysis, download the Index report.